Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 2426

Search results for: adverse events

2426 The Safety Profile of Vilazodone: A Study on Post-Marketing Surveillance

Authors: Humraaz Kaja, Kofi Mensah, Frasia Oosthuizen


Background and Aim: Vilazodone was approved in 2011 as an antidepressant to treat the major depressive disorder. As a relatively new drug, it is not clear if all adverse effects have been identified. The aim of this study was to review the adverse effects reported to the WHO Programme for International Drug Monitoring (PIDM) in order to add to the knowledge about the safety profile and adverse effects caused by vilazodone. Method: Data on adverse effects reported for vilazodone was obtained from the database VigiAccess managed by PIDM. Data was extracted from VigiAccess using Excel® and analyzed using descriptive statistics. The data collected was compared to the patient information leaflet (PIL) of Viibryd® and the FDA documents to determine adverse drug reactions reported post-marketing. Results: A total of 9708 adverse events had been recorded on VigiAccess, of which 6054 were not recorded on the PIL and the FDA approval document. Most of the reports were received from the Americas and were for adult women aged 45-64 years (24%, n=1059). The highest number of adverse events reported were for psychiatric events (19%; n=1889), followed by gastro-intestinal effects (18%; n=1839). Specific psychiatric disorders recorded included anxiety (316), depression (208), hallucination (168) and agitation (142). The systematic review confirmed several psychiatric adverse effects associated with the use of vilazodone. The findings of this study suggested that these common psychiatric adverse effects associated with the use of vilazodone were not known during the time of FDA approval of the drug and is not currently recorded in the patient information leaflet (PIL). Conclusions: In summary, this study found several adverse drug reactions not recorded in documents emanating from clinical trials pre-marketing. This highlights the importance of continued post-marketing surveillance of a drug, as well as the need for further studies on the psychiatric adverse events associated with vilazodone in order to improve the safety profile.

Keywords: adverse drug reactions, pharmacovigilance, post-marketing surveillance, vilazodone

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2425 Effect of Smartphone Applications on Patients' Knowledge of Surgery-Related Adverse Events during Hospitalization

Authors: Eunjoo Lee


Background: As the number of surgeries increases, the incidence of adverse events is likely to become more prevalent. Patients who are somewhat knowledgeable about surgery-related adverse events are more likely to engage in safety initiatives to prevent them. Objectives: To evaluate the impact of a smartphone application developed during the study to enhance patients’ knowledge of surgery-related adverse events during hospitalization. Design: Non-randomized, one group, measured pre- and post-intervention. Participants: Thirty-six hospitalized patients admitted to the orthopedics unit of a general hospital in South Korea. Methods. First, a smartphone application to enhance patients’ knowledge of surgery-related adverse events was developed through an iterative process, which included a literature review, expert consultation, and pilot testing. The application was installed on participants’ smartphones, and research assistants taught the participants to use it. Twenty-five true/false questions were used to assess patients’ knowledge of preoperative precautions (eight items), surgical site infection (five items), Foley catheter management (four items), drainage management (four items), and anesthesia-related complications (four items). Results: Overall, the percentage of correct answers increased significantly, from 57.02% to 73.82%, although answers related to a few specific topics did not increase that much. Although the patients’ understanding of drainage management and the Foley catheter did increase substantially after they used the smartphone application, it was still relatively low. Conclusions: The smartphone application developed during this study enhanced the patients’ knowledge of surgery-related adverse events during hospitalization. However, nurses must make an additional effort to help patients to understand certain topics, including drainage and Foley catheter management. Relevance to clinical practice: Insufficient patient knowledge increases the risk of adverse events during hospitalization. Nurses should take active steps to enhance patients’ knowledge of a range of safety issues during hospitalization, in order to decrease the number of surgery-related adverse events.

Keywords: patient education, patient participation, patient safety, smartphone application, surgical errors

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2424 Effect on Tolerability and Adverse Events in Participants Receiving Naltrexone/Bupropion and Antidepressant Medication, Including SSRIs, in a Large Randomized Double-Blind Study

Authors: Kye Gilder, Kevin Shan, Amy Halseth, Steve Smith


This study assessed the effect of prolonged-release naltrexone 32 mg/bupropion 360 mg (NB) on cardiovascular (CV) events in overweight/obese participants at elevated CV risk. Participants must lose ≥2% body weight at 16 wks, without a sustained increase in blood pressure, to continue drug. Only serious adverse events (SAE) and adverse events leading to discontinuation of study drug (AELDSD) were collected. The study was terminated early after second interim analysis with 50% of all CV events. Data on CV endpoints has been published. Current analyses focused on AEs in participants on antidepressants at baseline, as these individuals were excluded from Phase 3 trials. Intent-to-treat (ITT) population (placebo [PBO] N=4450, NB N=4455) was 54.5% female, 83.5% white, mean age of 61 yrs, mean BMI 37.3 kg/m2, 22.8% with a history of depression, 23.1% on antidepressants, including 15.4% on an SSRI. SAEs in participants receiving antidepressants was similar between NB (10.7%) and PBO (9.9%) and also similar to overall population (9.5% NB, 8.1% PBO). SAEs in those on SSRIs were similar, 10.1% NB and PBO 9.4%. For those on SSRIs or other antidepressants, AELDSDs were similar to overall population and were primarily GI disorders. Obesity increases the risk of developing depression. For participants taking NB and antidepressants, including SSRIs, there is a similar AE profile as the overall population and data revealed no evidence of an additional health risk with combined use.

Keywords: antidepressant, Contrave, Mysimba, obesity, pharmacotherapy

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2423 Applying the Global Trigger Tool in German Hospitals: A Retrospective Study in Surgery and Neurosurgery

Authors: Mareen Brosterhaus, Antje Hammer, Steffen Kalina, Stefan Grau, Anjali A. Roeth, Hany Ashmawy, Thomas Gross, Marcel Binnebosel, Wolfram T. Knoefel, Tanja Manser


Background: The identification of critical incidents in hospitals is an essential component of improving patient safety. To date, various methods have been used to measure and characterize such critical incidents. These methods are often viewed by physicians and nurses as external quality assurance, and this creates obstacles to the reporting events and the implementation of recommendations in practice. One way to overcome this problem is to use tools that directly involve staff in measuring indicators of quality and safety of care in the department. One such instrument is the global trigger tool (GTT), which helps physicians and nurses identify adverse events by systematically reviewing randomly selected patient records. Based on so-called ‘triggers’ (warning signals), indications of adverse events can be given. While the tool is already used internationally, its implementation in German hospitals has been very limited. Objectives: This study aimed to assess the feasibility and potential of the global trigger tool for identifying adverse events in German hospitals. Methods: A total of 120 patient records were randomly selected from two surgical, and one neurosurgery, departments of three university hospitals in Germany over a period of two months per department between January and July, 2017. The records were reviewed using an adaptation of the German version of the Institute for Healthcare Improvement Global Trigger Tool to identify triggers and adverse event rates per 1000 patient days and per 100 admissions. The severity of adverse events was classified using the National Coordinating Council for Medication Error Reporting and Prevention. Results: A total of 53 adverse events were detected in the three departments. This corresponded to adverse event rates of 25.5-72.1 per 1000 patient-days and from 25.0 to 60.0 per 100 admissions across the three departments. 98.1% of identified adverse events were associated with non-permanent harm without (Category E–71.7%) or with (Category F–26.4%) the need for prolonged hospitalization. One adverse event (1.9%) was associated with potentially permanent harm to the patient. We also identified practical challenges in the implementation of the tool, such as the need for adaptation of the global trigger tool to the respective department. Conclusions: The global trigger tool is feasible and an effective instrument for quality measurement when adapted to the departmental specifics. Based on our experience, we recommend a continuous use of the tool thereby directly involving clinicians in quality improvement.

Keywords: adverse events, global trigger tool, patient safety, record review

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2422 Stress Hyperglycemia: A Predictor of Major Adverse Cardiac Events in Non-Diabetic Patients With Acute Heart Failure

Authors: Fahad Raj Khan, Suleman Khan


There is a lack of consensus about the predictive value of raised blood glucose levels in terms of major adverse cardiac events (MACEs) in non-diabetic patients admitted for acute decompensated heart failure. The purpose of this research was to examine the long-term prognosis of acute decompensated heart failure (ADHF) in non-diabetic persons who had increased blood glucose levels, i.e., stress hyperglycemia, at the time of their ADHF hospitalization. The research involved 650 non-diabetic patients. Based on their admission stress hyperglycemia, they were divided into two with and without (SHGL). The two groups' one-year outcomes for major adverse cardiac events (MACEs) were compared, and key predictors of MACEs were discovered. For statistical analysis, the two-tailed Mann-Whitney U test, Fisher's exact test, and binary logistic regression analysis were utilized. SHGL was found in 353 (54.3%) individuals. It was more frequent in men than in women. About 27% of patients with SHGL had previously been admitted for ADHF. Almost 62% were hypertensive, whereas 14 % had CKD. MACEs were significantly predicted by SHGL, HTN, prior hospitalization for ADHF, CKD, and cardiogenic shock upon admission. SHGL at the time of ADHF admission, independent of DM status, may be a predictive indication of MACEs.

Keywords: stress hyperglycemia, acute heart failure, major adverse cardiac events, MACEs

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2421 Study of Reporting System for Adverse Events Related to Common Medical Devices at a Tertiary Care Public Sector Hospital in India

Authors: S. Kurian, S. Satpathy, S. K. Gupta, S. Arya, D. K. Sharma


Advances in the use of health care technology have resulted in increased adverse events (AEs) related to the use of medical devices. The study focused on the existing reporting systems. This study was conducted in a tertiary care public sector hospital. Devices included Syringe infusion pumps, Cardiac monitors, Pulse oximeters, Ventilators and Defibrillators. A total of 211 respondents were recruited. Interviews were held with 30 key informants. Medical records were scrutinized. Relevant statistical tests were used. Resident doctors reported maximum frequency of AEs, followed by nurses; and least by consultants. A significant association was found between the cadre of health care personnel and awareness that the patients and bystanders have a risk of sustaining AE. Awareness regarding reporting of AEs was low, and it was generally done verbally. Other critical findings are discussed in the light of the barriers to reporting, reasons for non-compliance, recording system, and so on.

Keywords: adverse events, health care technology, medical devices, public sector hospital, reporting systems

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2420 An Assessment of Adverse Events Following Immunization Reporting Pattern of Selected Vaccines in VigiAccess

Authors: Peter Yamoah, Frasia Oosthuizen


Introduction: Reporting of Adverse Events Following Immunization continues to be a challenge. Pharmacovigilance centers throughout the world are mandated by the WHO to submit AEFI reports from various countries to a large pool of adverse drug reaction electronic database called Vigibase. Despite the relevant information of AEFI in Vigibase, it is unavailable to the general public. However, the WHO has an alternative website called VigiAccess which is an open access website serving as a repository of reported adverse drug reactions and AEFIs. The aim of the study was to ascertain the reporting pattern of a number of commonly used vaccines in VigiAccess. Methods: VigiAccess was thoroughly searched on the 5th of February 2018 for AEFI reports of measles vaccine, oral polio vaccine (OPV), yellow fever vaccine, pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine, tetanus vaccine and tuberculosis (BCG) vaccine. These were reports from all pharmacovigilance centers in the world from the time they joined the WHO drug monitoring program. Results: After a thorough search in VigiAccess, there were 9,062 measles vaccine AEFIs, 185,829 OPV AEFIs, 24,577 yellow fever vaccine AEFIs, 317,208 pneumococcal vaccine AEFIs, 73,513 rotavirus vaccine AEFIs, 145,447 meningococcal vaccine AEFIs, 22,781 tetanus vaccine AEFIs and 35,556 BCG vaccine AEFIs. Conclusion: The study revealed that out of the eight vaccines studied, pneumococcal vaccines are associated with the highest number of AEFIs whilst measles vaccines were associated with the least AEFIs.

Keywords: vaccines, adverse reactions, VigiAccess, adverse event reporting

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2419 Using Group Concept Mapping to Identify a Pharmacy-Based Trigger Tool to Detect Adverse Drug Events

Authors: Rodchares Hanrinth, Theerapong Srisil, Peeraya Sriphong, Pawich Paktipat


The trigger tool is the low-cost, low-tech method to detect adverse events through clues called triggers. The Institute for Healthcare Improvement (IHI) has developed the Global Trigger Tool for measuring and preventing adverse events. However, this tool is not specific for detecting adverse drug events. The pharmacy-based trigger tool is needed to detect adverse drug events (ADEs). Group concept mapping is an effective method for conceptualizing various ideas from diverse stakeholders. This technique was used to identify a pharmacy-based trigger to detect adverse drug events (ADEs). The aim of this study was to involve the pharmacists in conceptualizing, developing, and prioritizing a feasible trigger tool to detect adverse drug events in a provincial hospital, the northeastern part of Thailand. The study was conducted during the 6-month period between April 1 and September 30, 2017. Study participants involved 20 pharmacists (17 hospital pharmacists and 3 pharmacy lecturers) engaging in three concept mapping workshops. In this meeting, the concept mapping technique created by Trochim, a highly constructed qualitative group technic for idea generating and sharing, was used to produce and construct participants' views on what triggers were potential to detect ADEs. During the workshops, participants (n = 20) were asked to individually rate the feasibility and potentiality of each trigger and to group them into relevant categories to enable multidimensional scaling and hierarchical cluster analysis. The outputs of analysis included the trigger list, cluster list, point map, point rating map, cluster map, and cluster rating map. The three workshops together resulted in 21 different triggers that were structured in a framework forming 5 clusters: drug allergy, drugs induced diseases, dosage adjustment in renal diseases, potassium concerning, and drug overdose. The first cluster is drug allergy such as the doctor’s orders for dexamethasone injection combined with chlorpheniramine injection. Later, the diagnosis of drug-induced hepatitis in a patient taking anti-tuberculosis drugs is one trigger in the ‘drugs induced diseases’ cluster. Then, for the third cluster, the doctor’s orders for enalapril combined with ibuprofen in a patient with chronic kidney disease is the example of a trigger. The doctor’s orders for digoxin in a patient with hypokalemia is a trigger in a cluster. Finally, the doctor’s orders for naloxone with narcotic overdose was classified as a trigger in a cluster. This study generated triggers that are similar to some of IHI Global trigger tool, especially in the medication module such as drug allergy and drug overdose. However, there are some specific aspects of this tool, including drug-induced diseases, dosage adjustment in renal diseases, and potassium concerning which do not contain in any trigger tools. The pharmacy-based trigger tool is suitable for pharmacists in hospitals to detect potential adverse drug events using clues of triggers.

Keywords: adverse drug events, concept mapping, hospital, pharmacy-based trigger tool

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2418 Causes and Impacts of Marine Heatwaves in the Bay of Bengal Region in the Recent Period

Authors: Sudhanshu Kumar, Raghvendra Chandrakar, Arun Chakraborty


In the ocean, the temperature extremes have the potential to devastate marine habitats, ecosystems together with ensuing socioeconomic consequences. In recent years, these extreme events are more frequent and intense globally and their increasing trend is expected to continue in the upcoming decades. It recently attracted public interest, as well as scientific researchers, which motivates us to analyze the current marine heatwave (MHW) events in the Bay of Bengal region. we have isolated 107 MHW events (above 90th percentile threshold) in this region of the Indian Ocean and investigated the variation in duration, intensity, and frequency of MHW events during our test period (1982-2021). Our study reveals that in the study region the average of three MHW events per year with an increasing linear trend of 1.11 MHW events per decade. In the analysis, we found the longest MHW event which lasted about 99 days, which is far greater than an average MHW event duration. The maximum intensity was 5.29°C (above the climatology-mean), while the mean intensity was 2.03°C. In addition, we observed net heat flux accompanied by anticyclonic eddies to be the primary cause of these events. Moreover, we concluded that these events affect sea surface height and oceanic productivity, highlighting the adverse impact of MHWs on marine ecosystems.

Keywords: marine heatwaves, global warming, climate change, sea surface temperature, marine ecosystem

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2417 Clinical Efficacy of Nivolumab and Ipilimumab Combination Therapy for the Treatment of Advanced Melanoma: A Systematic Review and Meta-Analysis of Clinical Trials

Authors: Zhipeng Yan, Janice Wing-Tung Kwong, Ching-Lung Lai


Background: Advanced melanoma accounts for the majority of skin cancer death due to its poor prognosis. Nivolumab and ipilimumab are monoclonal antibodies targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocytes antigen 4 (CTLA-4). Nivolumab and ipilimumab combination therapy has been proven to be effective for advanced melanoma. This systematic review and meta-analysis are to evaluate its clinical efficacy and adverse events. Method: A systematic search was done on databases (Pubmed, Embase, Medline, Cochrane) on 21 June 2020. Search keywords were nivolumab, ipilimumab, melanoma, and randomised controlled trials. Clinical trials fulfilling the inclusion criteria were selected to evaluate the efficacy of combination therapy in terms of prolongation of progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). The odd ratios and distributions of grade 3 or above adverse events were documented. Subgroup analysis was performed based on PD-L1 expression-status and BRAF-mutation status. Results: Compared with nivolumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR in combination therapy were 0.64 (95% CI, 0.48-0.85; p=0.002), 0.84 (95% CI, 0.74-0.95; p=0.007) and 1.76 (95% CI, 1.51-2.06; p < 0.001), respectively. Compared with ipilimumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR were 0.46 (95% CI, 0.37-0.57; p < 0.001), 0.54 (95% CI, 0.48-0.61; p < 0.001) and 6.18 (95% CI, 5.19-7.36; p < 0.001), respectively. In combination therapy, the odds ratios of grade 3 or above adverse events were 4.71 (95% CI, 3.57-6.22; p < 0.001) compared with nivolumab monotherapy, and 3.44 (95% CI, 2.49-4.74; p < 0.001) compared with ipilimumab monotherapy, respectively. High PD-L1 expression level and BRAF mutation were associated with better clinical outcomes in patients receiving combination therapy. Conclusion: Combination therapy is effective for the treatment of advanced melanoma. Adverse events were common but manageable. Better clinical outcomes were observed in patients with high PD-L1 expression levels and positive BRAF-mutation.

Keywords: nivolumab, ipilimumab, advanced melanoma, systematic review, meta-analysis

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2416 Pharmacovigilance in Hospitals: Retrospective Study at the Pharmacovigilance Service of UHE-Oran, Algeria

Authors: Nadjet Mekaouche, Hanane Zitouni, Fatma Boudia, Habiba Fetati, A. Saleh, A. Lardjam, H. Geniaux, A. Coubret, H. Toumi


Medicines have undeniably played a major role in prolonging shelf life and improving quality. The absolute efficacy of the drug remains a lever for innovation, its benefit/risk balance is not always assured and it does not always have the expected effects. Prior to marketing, knowledge about adverse drug reactions is incomplete. Once on the market, phase IV drug studies begin. For years, the drug was prescribed with less care to a large number of very heterogeneous patients and often in combination with other drugs. It is at this point that previously unknown adverse effects may appear, hence the need for the implementation of a pharmacovigilance system. Pharmacovigilance represents all methods for detecting, evaluating, informing and preventing the risks of adverse drug reactions. The most severe adverse events occur frequently in hospital and that a significant proportion of adverse events result in hospitalizations. In addition, the consequences of hospital adverse events in terms of length of stay, mortality and costs are considerable. It, therefore, appears necessary to develop ‘hospital pharmacovigilance’ aimed at reducing the incidence of adverse reactions in hospitals. The most widely used monitoring method in pharmacovigilance is spontaneous notification. However, underreporting of adverse drug reactions is common in many countries and is a major obstacle to pharmacovigilance assessment. It is in this context that this study aims to describe the experience of the pharmacovigilance service at the University Hospital of Oran (EHUO). This is a retrospective study extending from 2011 to 2017, carried out on archived records of declarations collected at the level of the EHUO Pharmacovigilance Department. Reporting was collected by two methods: ‘spontaneous notification’ and ‘active pharmacovigilance’ targeting certain clinical services. We counted 217 statements. It involved 56% female patients and 46% male patients. Age ranged from 5 to 78 years with an average of 46 years. The most common adverse reaction was drug toxidermy. For the drugs in question, they were essentially according to the ATC classification of anti-infectives followed by anticancer drugs. As regards the evolution of declarations by year, a low rate of notification was noted in 2011. That is why we decided to set up an active approach at the level of some services where a resident of reference attended the staffs every week. This has resulted in an increase in the number of reports. The declarations came essentially from the services where the active approach was installed. This highlights the need for ongoing communication between all relevant health actors to stimulate reporting and secure drug treatments.

Keywords: adverse drug reactions, hospital, pharmacovigilance, spontaneous notification

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2415 Management Tools for Assessment of Adverse Reactions Caused by Contrast Media at the Hospital

Authors: Pranee Suecharoen, Ratchadaporn Soontornpas, Jaturat Kanpittaya


Background: Contrast media has an important role for disease diagnosis through detection of pathologies. Contrast media can, however, cause adverse reactions after administration of its agents. Although non-ionic contrast media are commonly used, the incidence of adverse events is relatively low. The most common reactions found (10.5%) were mild and manageable and/or preventable. Pharmacists can play an important role in evaluating adverse reactions, including awareness of the specific preparation and the type of adverse reaction. As most common types of adverse reactions are idiosyncratic or pseudo-allergic reactions, common standards need to be established to prevent and control adverse reactions promptly and effectively. Objective: To measure the effect of using tools for symptom evaluation in order to reduce the severity, or prevent the occurrence, of adverse reactions from contrast media. Methods: Retrospective review descriptive research with data collected on adverse reactions assessment and Naranjo’s algorithm between June 2015 and May 2016. Results: 158 patients (10.53%) had adverse reactions. Of the 1,500 participants with an adverse event evaluation, 137 (9.13%) had a mild adverse reaction, including hives, nausea, vomiting, dizziness, and headache. These types of symptoms can be treated (i.e., with antihistamines, anti-emetics) and the patient recovers completely within one day. The group with moderate adverse reactions, numbering 18 cases (1.2%), had hypertension or hypotension, and shortness of breath. Severe adverse reactions numbered 3 cases (0.2%) and included swelling of the larynx, cardiac arrest, and loss of consciousness, requiring immediate treatment. No other complications under close medical supervision were recorded (i.e., corticosteroids use, epinephrine, dopamine, atropine, or life-saving devices). Using the guideline, therapies are divided into general and specific and are performed according to the severity, risk factors and ingestion of contrast media agents. Patients who have high-risk factors were screened and treated (i.e., prophylactic premedication) for prevention of severe adverse reactions, especially those with renal failure. Thus, awareness for the need for prescreening of different risk factors is necessary for early recognition and prompt treatment. Conclusion: Studying adverse reactions can be used to develop a model for reducing the level of severity and setting a guideline for a standardized, multidisciplinary approach to adverse reactions.

Keywords: role of pharmacist, management of adverse reactions, guideline for contrast media, non-ionic contrast media

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2414 Incidence, Risk Factors and Impact of Major Adverse Events Following Paediatric Cardiac Surgery

Authors: Sandipika Gupta


Objective: Due to admirably low 30-day mortality rates for paediatric cardiac surgery, it is now pertinent to turn towards more intermediate-length outcomes such as morbidities closely associated with these surgeries. One such morbidity, major adverse events (MAE) comprises a group of adverse outcomes associated with paediatric cardiac surgery (e.g. cardiac arrest, major haemorrhage). Methods: This is a retrospective study that analysed the incidence and impact of MAE which was the primary outcome in the UK population. The data was collected in 5 centres between October 2015 and June 2017, amassing 3090 surgical episodes. The incidence and risk factors for MAE, were assessed through descriptive statistical analyses and multivariate logistic regression. The secondary outcomes of life status at 6 months and the length of hospital stay were also evaluated to understand the impact of MAE on patients. Results: Out of 3090 episodes, 134 (4.3%) had a postoperative MAE. The majority of the episodes were in: neonates (47%, P<0.001), high-risk cardiac diagnosis groups (20.1%, P<0.001), episodes with longer 5mes on the bypass (72.4%, P<0.001) and urgent surgeries (57.9%, P<0.001). Episodes reporting MAE also reported longer lengths of stay in hospital (29 days vs 9 days, P<0.001). Furthermore, patients experiencing MAE were at a higher risk of mortality at the 6-month life status check (mortality rates: 29.2% vs 2%, P<0.001).Conclusions: Key risk factors were identified. An important negative impact of MAE was found for patients. The identified risk factors could be used to profile and flag at-risk patients. Monitoring of MAE rates and closer investigation into the care pathway before and after individual MAEs in children’s heart units may lead to a reduction in these terrible events.


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2413 Operationalizing the Concept of Community Resilience through Community Capitals Framework-Based Index

Authors: Warda Ajaz


This study uses the ‘Community Capitals Framework’ (CCF) to develop a community resilience index that can serve as a useful tool for measuring resilience of communities in diverse contexts and backgrounds. CCF is an important analytical tool to assess holistic community change. This framework identifies seven major types of community capitals: natural, cultural, human, social, political, financial and built, and claims that the communities that have been successful in supporting healthy sustainable community and economic development have paid attention to all these capitals. The framework, therefore, proposes to study the community development through identification of assets in these major capitals (stock), investment in these capitals (flow), and the interaction between these capitals. Capital based approaches have been extensively used to assess community resilience, especially in the context of natural disasters and extreme events. Therefore, this study identifies key indicators for estimating each of the seven capitals through an extensive literature review and then develops an index to calculate a community resilience score. The CCF-based community resilience index presents an innovative way of operationalizing the concept of community resilience and will contribute toward decision-relevant research regarding adaptation and mitigation of community vulnerabilities to climate change-induced, as well as other adverse events.

Keywords: adverse events, community capitals, community resilience, climate change, economic development, sustainability

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2412 Development of Trigger Tool to Identify Adverse Drug Events From Warfarin Administered to Patient Admitted in Medical Wards of Chumphae Hospital

Authors: Puntarikorn Rungrattanakasin


Objectives: To develop the trigger tool to warn about the risk of bleeding as an adverse event from warfarin drug usage during admission in Medical Wards of Chumphae Hospital. Methods: A retrospective study was performed by reviewing the medical records for the patients admitted between June 1st,2020- May 31st, 2021. ADEs were evaluated by Naranjo’s algorithm. The international normalized ratio (INR) and events of bleeding during admissions were collected. Statistical analyses, including Chi-square test and Reciever Operating Characteristic (ROC) curve for optimal INR threshold, were used for the study. Results: Among the 139 admissions, the INR range was found to vary between 0.86-14.91, there was a total of 15 bleeding events, out of which 9 were mild, and 6 were severe. The occurrence of bleeding started whenever the INR was greater than 2.5 and reached the statistical significance (p <0.05), which was in concordance with the ROC curve and yielded 100 % sensitivity and 60% specificity in the detection of a bleeding event. In this regard, the INR greater than 2.5 was considered to be an optimal threshold to alert promptly for bleeding tendency. Conclusions: The INR value of greater than 2.5 (>2.5) would be an appropriate trigger tool to warn of the risk of bleeding for patients taking warfarin in Chumphae Hospital.

Keywords: trigger tool, warfarin, risk of bleeding, medical wards

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2411 Safety Profile of Human Papillomavirus Vaccines: A Post-Licensure Analysis of the Vaccine Adverse Events Reporting System, 2007-2017

Authors: Giulia Bonaldo, Alberto Vaccheri, Ottavio D'Annibali, Domenico Motola


The Human Papilloma Virus (HPV) was shown to be the cause of different types of carcinomas, first of all of the cervical intraepithelial neoplasia. Since the early 80s to today, thanks first to the preventive screening campaigns (pap-test) and following to the introduction of HPV vaccines on the market; the number of new cases of cervical cancer has decreased significantly. The HPV vaccines currently approved are three: Cervarix® (HPV2 - virus type: 16 and 18), Gardasil® (HPV4 - 6, 11, 16, 18) and Gardasil 9® (HPV9 - 6, 11, 16, 18, 31, 33, 45, 52, 58), which all protect against the two high-risk HPVs (6, 11) that are mainly involved in cervical cancers. Despite the remarkable effectiveness of these vaccines has been demonstrated, in the recent years, there have been many complaints about their risk-benefit profile due to Adverse Events Following Immunization (AEFI). The purpose of this study is to provide a support about the ongoing discussion on the safety profile of HPV vaccines based on real life data deriving from spontaneous reports of suspected AEFIs collected in the Vaccine Adverse Events Reporting System (VAERS). VAERS is a freely-available national vaccine safety surveillance database of AEFI, co-administered by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). We collected all the reports between January 2007 to December 2017 related to the HPV vaccines with a brand name (HPV2, HPV4, HPV9) or without (HPVX). A disproportionality analysis using Reporting Odds Ratio (ROR) with 95% confidence interval and p value ≤ 0.05 was performed. Over the 10-year period, 54889 reports of AEFI related to HPV vaccines reported in VAERS, corresponding to 224863 vaccine-event pairs, were retrieved. The highest number of reports was related to Gardasil (n = 42244), followed by Gardasil 9 (7212) and Cervarix (3904). The brand name of the HPV vaccine was not reported in 1529 cases. The two events more frequently reported and statistically significant for each vaccine were: dizziness (n = 5053) ROR = 1.28 (CI95% 1.24 – 1.31) and syncope (4808) ROR = 1.21 (1.17 – 1.25) for Gardasil. For Gardasil 9, injection site pain (305) ROR = 1.40 (1.25 – 1.57) and injection site erythema (297) ROR = 1.88 (1.67 – 2.10) and for Cervarix, headache (672) ROR = 1.14 (1.06 – 1.23) and loss of consciousness (528) ROR = 1.71 (1.57 – 1.87). In total, we collected 406 reports of death and 2461 cases of permanent disability in the ten-year period. The events consisting of incorrect vaccine storage or incorrect administration were not considered. The AEFI analysis showed that the most frequently reported events are non-serious and listed in the corresponding SmPCs. In addition to these, potential safety signals arose regarding less frequent and severe AEFIs that would deserve further investigation. This already happened with the referral of the European Medicines Agency (EMA) for the adverse events POTS (Postural Orthostatic Tachycardia Syndrome) and CRPS (Complex Regional Pain Syndrome) associated with anti-papillomavirus vaccines.

Keywords: adverse drug reactions, pharmacovigilance, safety, vaccines

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2410 Botulinum Toxin type A for Lower Limb Lengthening and Deformity Correction: A Systematic Review and Meta-analysis

Authors: Jawaher F. Alsharef, Abdullah A. Ghaddaf, Mohammed S. Alomari, Abdullah A. Al Qurashi, Ahmed S. Abdulhamid, Mohammed S. Alshehri, Majed Alosaimi


Botulinum toxin type A (BTX-A) is the most popular therapeutic agent for muscle relaxation and pain control. Lately, BTX-A injection received great interest as a part of multimodal pain management for lower limb lengthening and deformity correction. This systematic review aimed to determine the role of BTX-A injection in pain management for during lower limb lengthening and/or deformity correction. We searched Medline, Embase, and CENTRAL. We included randomized controlled trials (RCTs) that compared the BTX-A injection to placebo for individuals undergoing lower limb lengthening and/or deformity correction. We sought to evaluate the following outcomes: pain on visual analogue scale (VAS), range of motion parameters, average opioid consumption, and adverse events. The standardized mean difference (SMD) was used to represent continuous outcomes while risk ratio (RR) was used to represent dichotomous outcomes. A total of 4 RCTs that enrolled 257 participants (337 limbs) deemed eligible. Adjuvant BTX-A injection showed a significant reduction in post-operative pain compared to placebo (SMD=–0.28, 95% CI –0.53 to –0.04). No difference was found between BTX-A injection and placebo in terms of range of motion parameters, average opioid consumption, or adverse events after surgical limb lengthening and/or deformity correction (RR= 0.77, 95% CI –0.58 to 1.03). Conclusions: Adjuvant BTX-A injection conferred a discernible reduction in post-operative pain during surgical limb lengthening and/or deformity without increasing the risk of adverse events.

Keywords: botulinum toxin type A, limb lengthening, distraction osteogenesis, deformity correction, pain management

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2409 Inappropriate Prescribing Defined by START and STOPP Criteria and Its Association with Adverse Drug Events among Older Hospitalized Patients

Authors: Mohd Taufiq bin Azmy, Yahaya Hassan, Shubashini Gnanasan, Loganathan Fahrni


Inappropriate prescribing in older patients has been associated with resource utilization and adverse drug events (ADE) such as hospitalization, morbidity and mortality. Globally, there is a lack of published data on ADE induced by inappropriate prescribing. Our study is specific to an older population and is aimed at identifying risk factors for ADE and to develop a model that will link ADE to inappropriate prescribing. The design of the study was prospective whereby computerized medical records of 302 hospitalized elderly aged 65 years and above in 3 public hospitals in Malaysia (Hospital Serdang, Hospital Selayang and Hospital Sungai Buloh) were studied over a 7 month period from September 2013 until March 2014. Potentially inappropriate medications and potential prescribing omissions were determined using the published and validated START-STOPP criteria. Patients who had at least one inappropriate medication were included in Phase II of the study where ADE were identified by local expert consensus panel based on the published and validated Naranjo ADR probability scale. The panel also assessed whether ADE were causal or contributory to current hospitalization. The association between inappropriate prescribing and ADE (hospitalization, mortality and adverse drug reactions) was determined by identifying whether or not the former was causal or contributory to the latter. Rate of ADE avoidability was also determined. Our findings revealed that the prevalence of potential inappropriate prescribing was 58.6%. A total of ADEs were detected in 31 of 105 patients (29.5%) when STOPP criteria were used to identify potentially inappropriate medication; All of the 31 ADE (100%) were considered causal or contributory to admission. Of the 31 ADEs, 28 (90.3%) were considered avoidable or potentially avoidable. After adjusting for age, sex, comorbidity, dementia, baseline activities of daily living function, and number of medications, the likelihood of a serious avoidable ADE increased significantly when a potentially inappropriate medication was prescribed (odds ratio, 11.18; 95% confidence interval [CI], 5.014 - 24.93; p < .001). The medications identified by STOPP criteria, are significantly associated with avoidable ADE in older people that cause or contribute to urgent hospitalization but contributed less towards morbidity and mortality. Findings of the study underscore the importance of preventing inappropriate prescribing.

Keywords: adverse drug events, appropriate prescribing, health services research

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2408 Prevalence of Adverse Events in Children and Adolescents on Antiretroviral Therapy: Examining the Pediatric Cohort in the Eastern Cape

Authors: Shannon Glaspy, Gerald Boon, Jack Lambert


Studies on AE of highly active antiretroviral therapy (HAART) in children and adolescents are rare. The aim of this study is to observe the frequency of treatment limiting adverse drug reactions against years on ARVs and specific ARV regimen. Methods: A retrospective cohort study was conducted in East London, South Africa. All patient files in the pediatric (0 – 18 years) ARV cohort were examined, selecting only those patients started on HAART. ARV regimen changes explicitly due to AE, age on ARV treatment onset, age of AE onset, and gender were extrapolated. Eligible subjects were obtained from patient folders, anonymized and cross-referenced with data obtained from electronic records. A total of 1120 patients [592 male (52.9%) and 528 female (47.1%)] were charted by incidence and year. Additional information was extrapolated in cases where the patient experienced lipodystrophy and lipoatrophy to include the number of years on ARVs prior to the onset of the AE. Results: Of the 1120 HIV infected children of the hospital cohort, a total of 105 (9.37%) AE (53.3% male) observed were deemed eligible for the study due to completeness of medical history and agreement between electronic records and paper files. The AE cited were as follows: lipoatrophy 62 (5.53% of all subjects), lipodystrophy 27 (2.41%), neuropathy 9 (0.8%), anemia 2 (0.17%), Steven Johnsons Syndrome 1 (0.08%), elevated LFTs 1 (0.8%), breast hypertrophy (0.08%), gastritis 1 (0.08%) and rash 1 (0.08%). The most prevalence ARV regimens associated with the onset of the AE are: D4T/3TC/EFV 72 cases (64.86% of all AE), D4T/3TC/LOPr 24 cases (21.62%). Lipoatrophy and lipodystrophy combined represent 84.76% (89 cases) of all adverse events documented in this cohort. Within the 60 cases of lipoatrophy, the average number of years on ARVs associated with an AE is 3.54, with 14 cases experiencing an AE between 0-2 years of HAART. Within the 29 cases of lipodystrophy, the average number of years on ARVs associated with an AE is 3.89, with 4 cases experiencing an AE between 0-2 years on HAART. The regimen D4T/3TC/EFV is associated with 43 cases (71.66%) of lipoatrophy and 21 cases (72.41%) of lipodystrophy. D4T/3TC/LOPr is associated with 15 cases (25%) of lipoatrophy and 7 cases (24.14%) of lipodystrophy. The frequency of AE associated with ARV regimens could be misrepresented due to prevalence of different 1st line regimens which were not captured in this study, particularly with the systematic change of 1st line drugs from D4T to ABC in 2010. Conclusion: In this descriptive study we found a 9.37% prevalence of AE were significant enough to be treatment limiting among our cohort. Lipoatrophy accounted for 59.04% of all documented AE. Overall, D4T/3TC/EFV was associated with 64.86% of all AE, 71.66% of lipoatrophy cases and 72.41% of lipodystrophy cases.

Keywords: ARV, adverse events, HAART, pediatric

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2407 Novel Oral Anticoagulants (NOACS) Adherence and Bleeding Events in Atrial Fibrillation Patients: A Systematic Review and Meta-Analysis

Authors: Tadesse Melaku Abegaz, Akshaya Srikanth Bahagavathula, Abdulla Shehab Sheab, Asim Hassen


Objectives: Non-adherence and discontinuation of anticoagulant therapy lead to increased ischemic stroke risk and contributes to suboptimal outcomes of the anticoagulant treatment. This systematic review and meta-analysis were aimed to investigate the adherence to NOACs and adverse events in patients with AF. Methods: Original research articles conducted on patients with AF and using any NOACs (dabigatran, rivoraxaban and apixaban) reporting adherence for at least 35 days were included. Scientific databases including PubMed, Web of Science, and Google Scholar were searched using MeSH keywords to obtaining literature researched between 2008 to till June, 2016. Study characteristics, patient’s sociodemographic and clinical characteristics, medication adherence levels and bleeding events reported were recorded. Results: The overall sample size of the six studies is 1,640,157, with CHADS2 scores < 2 in 551 patients, CHADS2-VASc ≥ 2 in 62,232 AF patients. Three-forth [75.6% (95%CI= 66.5-84.8), p < 0.001] are adherent to NOACs. However, a higher rate [72.7% (62.5-82.9), p < 0.001] of adherence was observed with Dabigatran than Apixaban [59.9% (3.2-123.1), p=0.063] and Rivaroxaban [59.3% (38.7-80.0), p<0.001]. Sub-group analysis revealed that nearly 57% of the AF patients on NOACs have CHADS2 scores < 2 and 20% of these patients were non-adherent to NOACs. Overall bleeding events rate associated with NOACs non-adherent AF patients was found to be 7.5% (0.2-14.8), p=0.045. However, nearly 11.2% of AF patients experienced bleeding events were non-adherent to NOAC medications. A higher proportion of bleeding events were noticed with Dabigatran (14.7%). Conclusions: Adherence rates, while uniformly suboptimal, nevertheless varied considerably, lowest at 59.3% for rivaroxaban and 59.9% for apixaban, followed by dabigatran (75.6%). Overall bleeding events associated with NOACs rates were 7.5%. However, lower adherence to NOACs was associated with worse outcomes among patients with greater stroke risk.

Keywords: atrial fibrillation, bleeding events, meta-analysis, novel oral anticoagulants

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2406 Clinical and Microbiologic Efficacy and Safety of Imipenem Cilastatin Relebactam in Complicated Infections: A Meta-analysis

Authors: Syeda Sahra, Abdullah Jahangir, Rachelle Hamadi, Ahmad Jahangir, Allison Glaser


Background: Antimicrobial resistance is on the rise. The use of redundant and inappropriate antibiotics is contributing to recurrent infections and resistance. Newer antibiotics with more robust coverage for gram-negative bacteria are in great demand for complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), hospital-acquired bacterial pneumonia (H.A.B.P.), and ventilator-associated bacterial pneumonia (V.A.B.P.). Objective: We performed this meta-analysis to evaluate the efficacy and safety profile of a new antibiotic, Imipenem/cilastatin/relebactam, compared to other broad-spectrum antibiotics for complicated infections. Search Strategy: We conducted a systemic review search on PubMed, Embase, and Central Cochrane Registry. Selection Criteria: We included randomized clinical trials (R.C.T.s) with the standard of care as comparator arm with Imipenem/cilastatin/relebactam as intervention arm. Analysis: For continuous variables, the mean difference was used. For discrete variables, we used the odds ratio. For effect sizes, we used a confidence interval of 95%. A p-value of less than 0.05 was used for statistical significance. Analysis was done using a random-effects model irrespective of heterogeneity. Heterogeneity was evaluated using the I2 statistic. Results: The authors observed similar efficacy at clinical and microbiologic response levels on early follow-up and late follow-up compared to the established standard of care. The incidence of drug-related adverse events, serious adverse events, and drug discontinuation due to adverse events were comparable across both groups. Conclusion: Imipenem/cilastatin/relebactam has a non-inferior safety and efficacy profile compared to peer antibiotics to treat severe bacterial infections (cUTIs, cIAIs, H.A.B.P., V.A.B.P.).

Keywords: bacterial pneumonia, complicated intra-abdominal infections, complicated urinary tract infection, Imipenem, cilastatin, relebactam

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2405 Bayesian Meta-Analysis to Account for Heterogeneity in Studies Relating Life Events to Disease

Authors: Elizabeth Stojanovski


Associations between life events and various forms of cancers have been identified. The purpose of a recent random-effects meta-analysis was to identify studies that examined the association between adverse events associated with changes to financial status including decreased income and breast cancer risk. The same association was studied in four separate studies which displayed traits that were not consistent between studies such as the study design, location and time frame. It was of interest to pool information from various studies to help identify characteristics that differentiated study results. Two random-effects Bayesian meta-analysis models are proposed to combine the reported estimates of the described studies. The proposed models allow major sources of variation to be taken into account, including study level characteristics, between study variance, and within study variance and illustrate the ease with which uncertainty can be incorporated using a hierarchical Bayesian modelling approach.

Keywords: random-effects, meta-analysis, Bayesian, variation

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2404 Malnutrition Among Adult Hospitalized Orthopedic Patients: Nursing Role And Nutrition Screening

Authors: Ehsan Ahmed Yahia


Introduction: The nursing role in nutrition screening and assessing hospitalized patients is important. Malnutrition is a common and costly problem, particularly among hospitalized patients, and can have an adverse effect on the healing process. The study's goal is to assess the prevalence of malnutrition among adult hospitalized orthopedic patients and to detect the barriers to the nutrition screening process. Aim of the study: This study aimed to (a) assess the prevalence of malnutrition in hospitalized orthopedic patients and (b) evaluate the relationship between malnutrition and selected clinical outcomes. Material and Methods: This prospective field study was conducted for three months between 03/2022 and 06/2022 in the selected orthopedic departments in a teaching hospital affiliated withCairo University, Egypt. with a total number of one hundred twenty (120) patients. Patients' assessment included checking for malnutrition using the Nutritional Risk Screening Questionnaire. Patients at risk for malnourishment were defined as NRS score ≥ 3. Clinical outcomes under consideration included 1) length of hospitalization, 2) mobilization after surgery and conservative treatment, and 3) rate of adverse events. Results: This study found that malnutrition is a significant problem among patients hospitalized in an orthopedic ward. The prevalence of malnutrition was the highest in patients with lumbar spine and pelvis fractures, followed by the proximal femur and proximal humerus fractures. Patients at risk for malnutrition had significantly prolonged hospitalization, delayed postoperative mobilization, and increased incidence of adverse events.27.8% of the study sample were at risk for malnutrition. The highest prevalence of malnourishment was found in Septic Surgery with 32%, followed by Traumatology with 19.6% and Arthroplasty with 15.3%. A higher prevalence of malnutrition was detected among patients with typical fractures, such as lumbar spine and pelvis (46.7%), proximal femur (34.4%), and proximal humeral (23.7%) fractures. Additionally, patients at risk for malnutrition showed prolonged hospitalization (14.7 ± 11.1 vs. 21.2 ± 11.7 days), delayed postoperative mobilization (2.3 ± 2.9 vs. 4.1 ± 4.9 days), and delayed to mobilize after conservative treatment (1.1 ± 2.7 vs. 1.8 ± 1.9 days). A significant statistical correlation of NRS with individual parameters (Spearman's rank correlation, p < 0.05) was observed. The rate of adverse incidents in patients at risk for malnutrition was significantly higher than that of patients with a regular nutritional status (37.2% vs. 21.1%, p < 0.001). Conclusions: Our results indicate that the prevalence of malnutrition in surgical patients is significant. The nutritional status of patients with typical fractures is especially at risk. Prolonged hospitalization, delayed postoperative mobilization, and delayed mobilization after conservative treatment is significantly associated with malnutrition. In addition, the incidence of adverse events in patients at risk for malnutrition is significantly higher.

Keywords: malnutrition, nutritional risk screening, surgery, nursing, orthopedic nurse

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2403 Comparative Outcomes of Percutaneous Coronary Intervention in Smokers versus Non Nonsmokers Patients: Observational Studies

Authors: Pratima Tatke, Archana Avhad, Bhanu Duggal, Meeta Rajivlochan, Sujata Saunik, Pradip Vyas, Nidhi Pandey, Aditee Dalvi, Jyothi Subramanian


Background: Smoking is well established risk factor for the development and progression of coronary artery disease. It is strongly related to morbidity and mortality from cardiovascular causes. The aim of this study is to observe effect of smoking status on percutaneous coronary intervention(PCI) after 1 year. Methods: 2527 patients who underwent PCI at different hospital of Maharashtra(India) from 2012 to 2015 under the health insurance scheme which is launched by Health department, Government of Maharashtra for below poverty line(BPL) families which covers cardiology. Informed consent of patients was taken .They were followed by telephonic survey after 6months to 1year of PCI . Outcomes of interest included myocardial infarction, restenosis, cardiac rehospitalization, death, and a composite of events after PCI. Made group of two non smokers-1861 and smokers (including patients who quit at time of PCI )-659. Results: Statistical Analysis using Pearson’s chi square test revealed that there was trend seen of increasing incidence of death, Myocardial infarction and Restenosis in smokers than non smokers .Smokers had a greater death risk compared to nonsmoker; 5.7% and 5.1% respectively p=0.518. Also Repeat procedures (2.1% vs. 1.5% p=0.222), breathlessness (17.8% vs. 18.20% p=0.1) and Myocardial Infarction (7.3% vs. 10%) high in smoker than non smokers. Conclusion: Major adverse cardiovascular events (MACE) were observed even after successful PCI in smokers. Patients undergoing percutaneous coronary intervention should be encouraged to stop smoking.

Keywords: coronary artery diseases, major adverse cardiovascular events, percutaneous coronary intervention, smoking

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2402 Implementation of Environmental Sustainability into Event Management

Authors: Özlem Küçükakça


The world population is rapidly growing. In the last few decades, environmental protection and climate change have been remarked as a global concern. All events have their own ecological footprint. Therefore, all participants who take part in the events, from event organizer to audience should be responsible for reducing carbon emissions. Currently, there is a literature gap which investigates the relationship between events and environment. Hence, this study is conducted to investigate how to implement environmental sustainability in the event management. Therefore, a wide literature and also the UK festivals database have been investigated. Finally, environmental effects and the solution of reducing impacts at events were discussed.

Keywords: ecological footprint, environmental sustainability, events, sustainability

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2401 Comparison of the Efficacy of Ketamine-Propofol versus Thiopental Sodium-Fentanyl in Procedural Sedation in the Emergency Department: A Randomized Double-Blind Clinical Trial

Authors: Maryam Bahreini, Mostafa Talebi Garekani, Fatemeh Rasooli, Atefeh Abdollahi


Introduction: Procedural sedation and analgesia have been desirable to handle painful procedures. The trend to find the agent with more efficacy and less complications is still controversial; thus, many sedative regimens have been studied. This study tried to assess the effectiveness and adverse effects of thiopental sodium-fentanyl with the known medication, ketamine-propofol for procedural sedation in the emergency department. Methods: Consenting patients were enrolled in this randomized double-blind trial to receive either 1:1 ketamine-propofol (KP) or thiopental-fentanyl (TF) 1:1 mg: Mg proportion on a weight-based dosing basis to reach the sedation level of American Society of Anesthesiologist class III/IV. The respiratory and hemodynamic complications, nausea and vomiting, recovery agitation, patient recall and satisfaction, provider satisfaction and recovery time were compared. The study was registered in Iranian randomized Control Trial Registry (Code: IRCT2015111325025N1). Results: 96 adult patients were included and randomized, 47 in the KP group and 49 in the TF group. 2.1% in the KP group and 8.1 % in the TF group experienced transient hypoxia leading to performing 4.2 % versus 8.1 % airway maneuvers for 2 groups, respectively; however, no statistically significant difference was observed between 2 combinations, and there was no report of endotracheal placement or further admission. Patient and physician satisfaction were significantly higher in the KP group. There was no difference in respiratory, gastrointestinal, cardiovascular and psychiatric adverse events, recovery time and patient recall of the procedure between groups. The efficacy and complications were not related to the type of procedure or patients’ smoking or addiction trends. Conclusion: Ketamine-propofol and thiopental-fentanyl combinations were effectively comparable although KP resulted in higher patient and provider satisfaction. It is estimated that thiopental fentanyl combination can be as potent and efficacious as ketofol with relatively similar incidence of adverse events in procedural sedation.

Keywords: adverse effects, conscious sedation, fentanyl, propofol, ketamine, safety, thiopental

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2400 Adverse Childhood Experience of Domestic Violence and Domestic Mental Health Leading to Youth Violence: An Analysis of Selected Boroughs in London

Authors: Sandra Smart-Akande, Chaminda Hewage, Imtiaz Khan, Thanuja Mallikarachchi


According to UK police-recorded data, there has been a substantial increase in knife-related crime and youth violence in the UK since 2014 particularly in the London boroughs. These crime rates are disproportionally distributed across London with the majority of these crimes occurring in the highly deprived areas of London and among young people aged 11 to 24 with large discrepancies across ethnicity, age, gender and borough of residence. Comprehensive studies and literature have identified risk factors associated with a knife carrying among youth to be Adverse Childhood Experience (ACEs), poor mental health, school or social exclusion, drug dealing, drug using, victim of violent crime, bullying, peer pressure or gang involvement, just to mention a few. ACEs are potentially traumatic events that occur in childhood, this can be experiences or stressful events in the early life of a child and can lead to an increased risk of damaging health or social outcomes in the latter life of the individual. Research has shown that children or youths involved in youth violence have had childhood experience characterised by disproportionate adverse childhood experiences and substantial literature link ACEs to be associated with criminal or delinquent behavior. ACEs are commonly grouped by researchers into: Abuse (Physical, Verbal, Sexual), Neglect (Physical, Emotional) and Household adversities (Mental Illness, Incarcerated relative, Domestic violence, Parental Separation or Bereavement). To the author's best knowledge, no study to date has investigated how household mental health (mental health of a parent or mental health of a child) and domestic violence (domestic violence on a parent or domestic violence on a child) is related to knife homicides across the local authorities areas of London. This study seeks to address the gap by examining a large sample of data from the London Metropolitan Police Force and Characteristics of Children in Need data from the UK Department for Education. The aim of this review is to identify and synthesise evidence from data and a range of literature to identify the relationship between adverse childhood experiences and youth violence in the UK. Understanding the link between ACEs and future outcomes can support preventative action.

Keywords: adverse childhood experiences, domestic violence, mental health, youth violence, prediction analysis, London knife crime

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2399 Risk Assessment Tools Applied to Deep Vein Thrombosis Patients Treated with Warfarin

Authors: Kylie Mueller, Nijole Bernaitis, Shailendra Anoopkumar-Dukie


Background: Vitamin K antagonists particularly warfarin is the most frequently used oral medication for deep vein thrombosis (DVT) treatment and prophylaxis. Time in therapeutic range (TITR) of the international normalised ratio (INR) is widely accepted as a measure to assess the quality of warfarin therapy. Multiple factors can affect warfarin control and the subsequent adverse outcomes including thromboembolic and bleeding events. Predictor models have been developed to assess potential contributing factors and measure the individual risk of these adverse events. These predictive models have been validated in atrial fibrillation (AF) patients, however, there is a lack of literature on whether these can be successfully applied to other warfarin users including DVT patients. Therefore, the aim of the study was to assess the ability of these risk models (HAS BLED and CHADS2) to predict haemorrhagic and ischaemic incidences in DVT patients treated with warfarin. Methods: A retrospective analysis of DVT patients receiving warfarin management by a private pathology clinic was conducted. Data was collected from November 2007 to September 2014 and included demographics, medical and drug history, INR targets and test results. Patients receiving continuous warfarin therapy with an INR reference range between 2.0 and 3.0 were included in the study with mean TITR calculated using the Rosendaal method. Bleeding and thromboembolic events were recorded and reported as incidences per patient. The haemorrhagic risk model HAS BLED and ischaemic risk model CHADS2 were applied to the data. Patients were then stratified into either the low, moderate, or high-risk categories. The analysis was conducted to determine if a correlation existed between risk assessment tool and patient outcomes. Data was analysed using GraphPad Instat Version 3 with a p value of <0.05 considered to be statistically significant. Patient characteristics were reported as mean and standard deviation for continuous data and categorical data reported as number and percentage. Results: Of the 533 patients included in the study, there were 268 (50.2%) female and 265 (49.8%) male patients with a mean age of 62.5 years (±16.4). The overall mean TITR was 78.3% (±12.7) with an overall haemorrhagic incidence of 0.41 events per patient. For the HAS BLED model, there was a haemorrhagic incidence of 0.08, 0.53, and 0.54 per patient in the low, moderate and high-risk categories respectively showing a statistically significant increase in incidence with increasing risk category. The CHADS2 model showed an increase in ischaemic events according to risk category with no ischaemic events in the low category, and an ischaemic incidence of 0.03 in the moderate category and 0.47 high-risk categories. Conclusion: An increasing haemorrhagic incidence correlated to an increase in the HAS BLED risk score in DVT patients treated with warfarin. Furthermore, a greater incidence of ischaemic events occurred in patients with an increase in CHADS2 category. In an Australian population of DVT patients, the HAS BLED and CHADS2 accurately predicts incidences of haemorrhage and ischaemic events respectively.

Keywords: anticoagulant agent, deep vein thrombosis, risk assessment, warfarin

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2398 Adverse Reactions from Contrast Media in Patients Undergone Computed Tomography at the Department of Radiology, Srinagarind Hospital

Authors: Pranee Suecharoen, Jaturat Kanpittaya


Background: The incidence of adverse reactions to iodinated contrast media has risen. The dearth of reports on reactions to the administration of iso- and low-osmolar contrast media should be addressed. We, therefore, studied the profile of adverse reactions to iodinated contrast media; viz., (a) the body systems affected (b) causality, (c) severity, and (d) preventability. Objective: To study adverse reactions (causes and severity) to iodinated contrast media at Srinagarind Hospital. Method: Between March and July, 2015, 1,101 patients from the Department of Radiology were observed and interviewed for the occurrence of adverse reactions. The patients were classified per Naranjo’s algorithm and through use of an adverse reactions questionnaire. Results: A total of 105 cases (9.5%) reported adverse reactions (57% male; 43% female); among whom 2% were iso-osmolar vs. 98% low-osmolar. Diagnoses included hepatoma and cholangiocarcinoma (24.8%), colorectal cancer (9.5%), breast cancer (5.7%), cervical cancer (3.8%), lung cancer (2.9%), bone cancer (1.9%), and others (51.5%). Underlying diseases included hypertension and diabetes mellitus type 2. Mild, moderate, and severe adverse reactions accounted for 92, 5 and 3%, respectively. The respective groups of escalating symptoms included (a) mild urticaria, itching, rash, nausea, vomiting, dizziness, and headache; (b) moderate hypertension, hypotension, dyspnea, tachycardia and bronchospasm; and (c) severe laryngeal edema, profound hypotension, and convulsions. All reactions could be anticipated per Naranjo’s algorithm. Conclusion: Mild to moderate adverse reactions to low-osmolar contrast media were most common and these occurred immediately after administration. For patient safety and better outcomes, improving the identification of patients likely to have an adverse reaction is essential.

Keywords: adverse reactions, contrast media, computed tomography, iodinated contrast agents

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2397 The Prevalence of Cardiac Events in Elite Athletes of International Triathlon Sports Disciplines: An Internet-based Study From 2006-2019

Authors: Lingxia Li, Frédéric Schnell, Shuzhe Ding, Solène Le Douairon Lahaye


Background: The prevalence of adverse cardiac events in different triathlon sports disciplines has not been determined systematically despite important cardiovascular constraints. Purpose: The present study aimed to determine the prevalence of cardiac events in world-class elite triathletes according to their sex and triathlon disciplines (aquathlon, duathlon, triathlon…) and formats (short, long, and ultra-long distance) practiced. Methods: All male and female athletes from 11 triathlon disciplines, ranked in the internationally yearly top 10 between 2006 and 2019, were included. The name of each of them was associated in Google search with selected key terms related to heart disease and/or acute cardiac events during their inclusion date. The prevalence and the hazard function of sex and triathlon disciplines and formats variation were calculated, and the difference was then compared between all triathlon sports. Results: From 1320 athletes included (male 633, female 687), 13 cases of accidents (0.98%, 95% CI: [0.45-1.52]) were identified, average age was 29.1 ± 6.4, including 2 cardiac deaths in males (0.15%, 95% CI: [0.00-0.36]), and 3 progressed congenital cardiac disease. Short-distance formats (0.95%, 95% CI: [0.12-1.78]), especially short-distance triathlon (0.39%, 95% CI: [0.08-0.70]) were most affected than long-distance (0.00%, 95% CI: [0.00-0.00]) and ultra-long distance (0.00%, 95% CI: [0.00-0.00]). Interestingly, athletes who participated in two or three types of triathlon disciplines have a higher prevalence than athletes who participated in four and five types of sports disciplines (p < 0.01). No sex difference was found in different formats and each triathlon discipline (p > 0.05). Conclusion: Athletes in short-distance formats, especially short-distance triathlon, were more affected than long-distance and ultra-long distances. Athletes who participate in short-distance formats should be closely monitored regardless of male or female.

Keywords: cardiac events, sudden cardiac arrest/death, triathlon sports disciplines, world-class elite athletes

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